Chronic Hepatitis CIM1NCT01509391
Keyhole Limpet Hemocyanin in Chronic Hepatitis C
A study testing keyhole-limpet hemocyanin in people with Chronic Hepatitis C and Liver Cirrhosis, run by Medical University of Graz at 1 site in Austria.
Trial summary
In this study the investigators examine the safety and efficacy of Keyhole-limpet-hemocyanin in patients with chronic hepatitis c infection and liver cirrhosis. The investigators hypothesize that administration of keyhole-limpet-hemocyanin reduces the viral load in patients infected with hepatitis c. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Chronic Hepatitis C, Liver Cirrhosis
- What is being tested?
- keyhole-limpet hemocyanin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteAustria
- Study dates
- Jan 2012to Oct 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chronic Hepatitis C infection
- no previous therapy
- at least one contraindication to interferon therapy
- liver cirrhosis
- age between 18-80 y
- women of not childbearing age
Who cannot join
- Hypersensitivity against keyhole-limpet hemocyanin
- previous treatment against hepatitis c
- autoimmune disorders
- immunosuppression
- hepatocellular carcinoma or other malignancies
- coinfection with hepatitis b or HIV
Show all 10Show fewer
- pregnancy
- cardiovascular event during the last 6 months (stroke or MCI)
- uncontrolled diabetes
- renal insufficiency (GFR < 50 ml/min) or chronic hemodialysis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Keyhole Limpet Hemocyanin in Chronic Hepatitis C and Compensated Cirrhosis - Pilot Study IM1
In this study the investigators examine the safety and efficacy of Keyhole-limpet-hemocyanin in patients with chronic hepatitis c infection and liver cirrhosis. The investigators hypothesize that administration of keyhole-limpet-hemocyanin reduces the viral load in patients infected with hepatitis c.
- Conditions
- Chronic Hepatitis C, Liver Cirrhosis
- Being tested
- keyhole-limpet hemocyanin
- Medical subject headings
- Hepatitis C, Chronic, Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
keyhole-limpet hemocyaninDrug
Subcutaneous administration keyhole-limpet hemocyanin
| Study group | Role | What they receive |
|---|---|---|
| Keyhole-limpet hemocyanine | Experimental | Not described Receives: Drug: keyhole-limpet hemocyanin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hepatitis C viral load at week 24
Measured: 24 weeks
Secondary outcomes (1)
Hepatitis c viral load at weeks 1,2,4,8,12,18,32
Measured: 1,2,4,8,12,18,32 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2012 (estimated)
- Study startJan 2012
- Primary completionOct 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Hepatitis CStudies of the same condition, open and under way.
- More trials run by Medical University of GrazThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Graz
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rudolf Stauber, MD, Medical University of Graz
- Investigators
- Rudolf E Stauber, MD, Principal investigator, Medical University of Graz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01509391
- Sponsor's protocol ID
- HCVGRZ-IM1
- Acronym
- IM1
- Status last verified
- Oct 2012
- First submitted
- 9 Jan 2012
- Last updated
- 17 Oct 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Keyhole Limpet Hemocyanin in Chronic Hepatitis C and Compensated Cirrhosis - Pilot Study IM1
- ClinicalTrials.gov ID
- NCT01509391
- Acronym / sponsor ID
- IM1 / HCVGRZ-IM1
- Conditions
- Chronic Hepatitis C, Liver Cirrhosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Medical University of GrazUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 13 Jan 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this study the investigators examine the safety and efficacy of Keyhole-limpet-hemocyanin in patients with chronic hepatitis c infection and liver cirrhosis. The investigators hypothesize that administration of keyhole-limpet-hemocyanin reduces the viral load in patients infected with hepatitis c.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Keyhole-limpet hemocyanine | Experimental | Drug: keyhole-limpet hemocyanin |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Chronic Hepatitis C infection
- no previous therapy
- at least one contraindication to interferon therapy
- liver cirrhosis
- age between 18-80 y
Key exclusion criteria (10 listed)
- Hypersensitivity against keyhole-limpet hemocyanin
- previous treatment against hepatitis c
- autoimmune disorders
- immunosuppression
- hepatocellular carcinoma or other malignancies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| keyhole-limpet hemocyaninSubcutaneous administration keyhole-limpet hemocyanin | Drug | Keyhole-limpet hemocyanine |
Primary outcome
Hepatitis C viral load at week 24
Time frame: 24 weeks
1 secondary outcome
Hepatitis c viral load at weeks 1,2,4,8,12,18,32
Time frame: 1,2,4,8,12,18,32 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rudolf E Stauber, MD principal investigator
Medical University of Graz
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing keyhole-limpet hemocyanin in people with Chronic Hepatitis C and Liver Cirrhosis, run by Medical University of Graz at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hepatitis C viral load at week 24 (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2012.